ClinicalTrials.gg
CompletedNCT00161772Updated May 21, 2015

Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

A Phase 2 interventional study of Tick-borne Encephalitis Vaccine in Tick-borne Encephalitis, sponsored by Pfizer. Completed at 23 sites in 2 countries. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Pfizer · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.

02

Conditions studied

  • Tick-borne Encephalitis
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male and female children will be eligible for participation in this study if:

  • they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old;
  • they are clinically healthy;
  • their legal representative understands the nature of the study, agrees to its provisions and gives written ;
  • their legal representative agrees to keep a Volunteer Diary.

Exclusion criteria

Exclusion Criteria:

Children will be excluded from participation in this study if they:

  • have a history of any previous TBE vaccination;
  • have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
  • have a history of allergic reactions, in particular to one of the components of the vaccine;
  • have received antipyretics within 4 hours prior to the first TBE vaccination;
  • suffer from a disease that cannot be effectively treated or stabilized;
  • suffer from a disease (e.g. disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
  • suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
  • are known to be positive (a special HIV test is not required for the purpose of the study);
  • suffer from a febrile illness at study entry;
  • have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
  • are participating simultaneously in another clinical trial.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • BiologicalTick-borne Encephalitis Vaccine
06

Study locations

23 sites
  • Grieskirchner Strasse 17
    Wels, 4600, Austria
  • Neuschwansteinstrasse 5
    Augsburg, 86163, Germany
  • Marktplatz 3
    Bad Saulgau, 88348, Germany
  • Hauptstrasse 9
    Bietigheim-Bissingen, 74321, Germany
  • Salzgasse 11
    Calw, 75365, Germany
  • Mohrenstrasse 8
    Coburg, 96450, Germany
  • Bahnhofstrasse 1
    Elzach, 79215, Germany
  • Rheinstrasse 13
    Ettenheim, 77955, Germany
  • Peter-Seifert-Strasse 5
    Gersfeld, 36129, Germany
  • Solothurner Strasse 2
    Heilbronn, 74072, Germany
  • Hauptstraße 240
    Kehl, 77694, Germany
  • Schwarzwaldstrasse 20
    Kirchzarten, 79199, Germany
  • Altoettingerstrasse 3
    Landsberg, 86899, Germany
  • Rastatter Strasse 7
    Mannheim-Secken, 68239, Germany
  • Heubischer Strasse 39
    Neustadt/Cbg, 96465, Germany
  • Dohmbuehlerstrasse 8
    Nürnberg, 90449, Germany
  • Glogauer Strasse 15
    Nürnberg, 90473, Germany
  • Tuchbergstrasse 2
    Oberndorf / Neckar, 78727, Germany
  • Wilhelmstrasse 7
    Offenburg, 77654, Germany
  • Asternweg 11a
    Offenburg, 77656, Germany
  • Berneckstrasse 19
    Schrammberg, 78713, Germany
  • Hauptstrasse 11
    Tegernsee, 83681, Germany
  • Broner Platz 6
    Weingarten, 88250, Germany
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2002 and a completion of Aug 2002. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2005
First posted
Sep 13, 2005
Start
Mar 2002
Completion
Aug 2002
Last update
May 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00161772
Lead sponsor
Pfizer
First posted
Sep 13, 2005
Start date
Mar 2002
Completion
Aug 2002
Last update
May 21, 2015

Study contacts

Ulrich Behre, MD
principal investigator · Hauptstrasse 240, 77694 Kehl, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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